MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISC HUM 4X100MM LT FLANGED C; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	540-34-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to loosening and infection.
Additional Manufacturer Narrative
The reason for this revision surgery, the agent reported "(pt.Presented to dr.With loosening of the humeral component and suspected infection.Humeral component was removed and replaced.The ulna bearing appeared fine, however they were removed and replaced out of an abundance of caution.Condyle bearing were also replaced.Female 74 yrs)." the previous surgery and the surgery detailed in this event occurred 1.5 years apart.This evaluation is limited in scope as limited information was provided to djo surgical - austin for examination.If information regarding cultures identified in the infection, the severity of the infection, the loosening of the component or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to loosening of the humeral component and suspected infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have caused the loosening or contributed to the possible infection or inhibited the patient's immune system.There are multiple factors that may also contribute to an infection that are outside the control of djo surgical.

• Brand Name: DISC HUM 4X100MM LT FLANGED C
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 16924887
• Report Number: 1644408-2023-00585
• Device Sequence Number: 6921265
• Product Code: JDC
• UDI-Device Identifier: 00190446137702
• UDI-Public: 00190446137702
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K013042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 540-34-100
• Device Catalogue Number: 540-34-100
• Device Lot Number: 90403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 540-00-000 LOT: 84174.; 540-54-075 LOT: 826W1022.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female